Career Category

Job Description

Shift Schedule: 7:00am - 7:00pm

Under general supervision, employee will perform operations in the Manufacturing area, specifically Purification processes. Operations will be performed according to Standard Operating Procedures (SOPs). Employee will perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Employee will also perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent the Purification group. Employee may also have the responsibility of owning NC/CAPA’s and Change Control records. In addition, employee may identify, recommend, and implement improvements related to routine functions.

Basic Qualifications:

Bachelor's degree

OR

Associate's degree & 4 years of Manufacturing & Operations related experience

OR

High School diploma/GED & 6 years of Manufacturing & Operations related experience.

Preferred Qualifications:

• Knowledge of large scale Purification operations, chromatography, TFF, aseptic processing, etc.
• CFR and Regulatory knowledge Mechanical ability/expertise
• Knowledge of WIP lab equipment and computers, with LIMS access
• Basic statistical mathematical skills
• Ability to interpret and apply GMP knowledge
• Understanding of analytical methods for manufacturing area
• Ability to demonstrate technical writing capability with Trackwise access
• Able to demonstrate project management skills and presentation skills
• Independently collaborate with outside resources
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Basic troubleshooting skills on Purification equipment
• Experience with Delta V, RD’s